Tag: patient-driven drug development

How to Prepare Paediatric Investigational Plans (PIPs) for ATMPs: Key Clinical Science Insights

Paediatric clinical development considerations for ATMPs

Advanced Therapeutic Medicinal Products (ATMPs)—which include gene therapies, cell therapies, and tissue-engineered products — represent a new frontier in medicine, particularly in addressing serious and life-threatening conditions. To ensure that these innovative therapies are safe and effective for children, the preparation of Paediatric Investigational Plans (PIPs) is crucial. Under Paediatric Regulation (EC) No 1901/2006, [1] continue reading…

Patient-Driven Drug Development: Does Patient Involvement Truly Improve the Success Rates of New Treatments?

In recent years, the biotechnology industry has seen a transformative shift towards patient-driven drug development. At 3D-PharmXchange, we have experienced firsthand the impact that patient involvement can have on the development of new therapies. It has already been well described that patients bring a unique perspective that often reshapes the design of clinical trials. Their continue reading…